China NMPA Inspection - Yongcheng Science and Technology Experimental Plant - August 18, 2020

The National Medical Products Administration (NMPA) conducted an unannounced inspection of Yongcheng City Science and Technology Experimental Plant prior to August 6, 2020, identifying severe deficiencies in its quality management system. The company was found to be non-compliant with the Good Manufacturing Practice for Medical Devices (GMP) and its Appendix for Sterile Medical Devices. Major violations included insufficient qualified personnel, specifically a lack of full-time inspectors capable of performing critical product testing like nitrogen content and adhesive strength. Facility issues involved inadequate cleanroom purification systems, relying on fan filter units without primary or secondary filters, and lacking proper original data for environmental monitoring. Production management also showed critical flaws, such as the absence of inspection status markings for products and work orders, indicating a lack of traceability, and a failure to perform required terminal sterilization on products. In response, the NMPA, via the Henan Provincial Medical Products Administration, ordered an immediate cessation of production for rectification. Yongcheng City Science and Technology Experimental Plant is required to assess product safety risks, recall any hazardous products, and can only resume production after successfully completing all corrective actions and passing a re-inspection by the provincial authority. The NMPA announced these findings and directives on August 18, 2020.